Company: Linvatec Corp. dba ConMed Linvatec
Date of Enforcement Report: 5/29/2013
Class ll:
PRODUCT
Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. Recall Number Z-1340-2013
REASON
The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL on 3/18/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
267 units
DISTRIBUTION
Nationwide and Internationally
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